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Re-licensing Study to Assess Inflexal V Formulated With WHO Recommended Influenza Strains

NCT ID: NCT01631110

Last Updated: 2013-12-20

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2012-08-31

Brief Summary

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The study is to assess whether the influenza vaccine Inflexal V for season 2012/2013 fulfills the EMA requirements for re-registration of influenza vaccines.

Detailed Description

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Conditions

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Influenza

Keywords

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Influenza Virus Vaccination Inflexal V

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Elderly subjects aged over 60 years

Group Type EXPERIMENTAL

Inflexal V

Intervention Type BIOLOGICAL

Intramuscular administration (M. deltoideus) of a single dose of 0.5 mL Inflexal V

Adults from 18 to 60 years old inclusive

Group Type EXPERIMENTAL

Inflexal V

Intervention Type BIOLOGICAL

Intramuscular administration (M. deltoideus) of a single dose of 0.5 mL Inflexal V

Interventions

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Inflexal V

Intramuscular administration (M. deltoideus) of a single dose of 0.5 mL Inflexal V

Intervention Type BIOLOGICAL

Other Intervention Names

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Inflexal V influenza vaccine (surface antigen, inactivated, virosome) formulated for the WHO requirements of the 2012-2013 season, each 0.5 mL dose containing: • 15 µg HA antigen of A/California/7/2009 (H1N1)-like virus • 15 µg HA antigen of A/Victoria/361/2011 (H3N2)-like virus • 15 µg HA antigen of B/Wisconsin/1/2010-like virus

Eligibility Criteria

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Inclusion Criteria

* Healthy female and male adults aged ≥18 on Day 1
* Written informed consent
* Female subjects of childbearing potential using and willing to continue using an acceptable method of contraception unless surgically sterilized/hysterectomized or post-menopausal for more than 2 years

Exclusion Criteria

* Acute exacerbation of bronchopulmonary infection (cough, sputum, lung findings) or other acute disease
* Acute febrile illness (≥38.0 °C)
* Prior vaccination with an influenza vaccine in the past 330 days
* Known hypersensitivity to any vaccine component
* Previous history of a serious adverse reaction to influenza vaccine
* History of egg protein allergy or severe atopy
* Known blood coagulation disorder
* Chronic (longer than 14 days) administration of immunosuppressants or other immune-modifying drugs within 6 months before the first dose of the study vaccine, including oral corticosteroids in dosages of ≥0.5 mg/kg/d prednisolone or equivalent (inhaled or topical steroids are allowed)
* Known immunodeficiency (incl. leukemia, HIV seropositivity), cancer
* Investigational medicinal product received in the past 3 months (90 days)
* Treatment with immunoglobulins or blood transfusion(s) received in the past 3 months (90 days)
* Pregnancy or lactation
* Participation in another clinical trial
* Employee at the investigational site, or relative of the investigator
* Subjects who in the view of the investigator will not comply with study procedures and/or visit requirements as per protocol
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Crucell Holland BV

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael Seiberling, MD

Role: PRINCIPAL_INVESTIGATOR

Covance Clinical Research Unit AG

Locations

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Covance Clinical Research Unit AG

Allschwil, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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INF-V-A010

Identifier Type: -

Identifier Source: org_study_id